Function Following Thumb MP Fusion and IP Fusion

NCT03661281 | Completed DMC

• 1 other identifier: 17-01281
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine function following simulated thumb metacarpophalangeal (MP) and thumb interphalangeal (IP) joint fusion. The investigators want to determine the functional limitation created by MP and IP joint fusion. 20-30 volunteers will be fitted for custom molded orthoplast splints immobilizing either the MP or IP joint. The volunteers will then be taken through multiple tests including lateral pinch strength, tip pinch, grip strength, grooved pegboard test time, and Jebson Taylor test. Each patient will be tested without a splint, with their MP joint immobilized and with their IP joint immobilized. The results of this study can be used for patient education before surgery in order to help them make informed decisions as well as manage expectations. It can also serve as a decision aid in pinch restoration in the context of ulnar nerve palsy.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Jebsen Taylor hand function test

  This consists of seven test items, which are felt to represent various hand activities. Each activity will be timed.

  1 Month

Study Arms (1)

Simulated Thumb Arthrodesis

EXPERIMENTAL

Subjects will have their thumb immobilized in 2 prefabricated wrist splints to simulate 2 different fusion positions tested: one splint to simulate the MCP fusion and one to represent the IP fusion. Patients will complete hand function tests in each of the splints to evaluate hand function.

Diagnostic Test: Jebsen Taylor Hand function test; Diagnostic Test: Pinch strength; Diagnostic Test: Grooved pegboard test

Interventions

Jebsen Taylor Hand function test DIAGNOSTIC_TEST

consists of seven test items, which are felt to represent various hand activities. These test items include: writing a short sentence; turning over 365 inch cards; picking up small objects and placing in a container; stacking checkers; simulated eating; moving empty large cans; and moving weighted large cans.

Simulated Thumb Arthrodesis

Pinch strength DIAGNOSTIC_TEST

Measured in every splint position using a standard dynamometer

Simulated Thumb Arthrodesis

Grooved pegboard test DIAGNOSTIC_TEST

Time will be measured and compared between control, MP splint and IP splint

Simulated Thumb Arthrodesis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a healthy volunteer
• Patient is willing and able to review and sign a study informed consent form

You may not qualify if:

• Any subject who does not want to voluntarily participate.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Pinch Strength

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hand Strength; Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eitan Melamed, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: September 7, 2018
• Study Start: February 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 24, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

US (1)